European Commission Approves Split-Dose of Daratumumab in Multiple Myeloma
Posted: Wednesday, January 30, 2019
It has been announced that the European Commission has granted authorization to provide health-care professionals with the option to split the first infusion of daratumumab for patients with multiple myeloma. The approval follows the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Daratumumab is a first-in-class biologic targeting CD38 regardless of disease stage and is believed to induce tumor cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis, as well as through apoptosis.
The decision was based on data from the phase Ib EQUULEUS study (ClinicalTrials.gov identifier NCT01998971), which demonstrated that the pharmacokinetics concentrations of daratumumab were comparable regardless of whether the first dose was administered as a split infusion or a single first infusion in patients with multiple myeloma. The safety profile of daratumumab was comparable when administered initially as a split or a single dose.